Food and Drug Administration (FDA)
NEWS
The U.S. Food and Drug Administration (FDA) is warning consumers who seek to buy medications through websites that they may be opening themselves up to of a swarm of imposters claiming to be representatives of the regulatory agency.
Amgen and UCB resubmitted their Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for Evenity (romosozumab).
The U.S. Drug Enforcement Agency is in the midst of readdressing cannabis following the regulatory approval of the first cannabinoid-based drug for the treatment of some epilepsy patients.
Zogenix announced positive top-line data from its second confirmatory Phase III clinical trial of ZX008 (low-dose fenfluramine hydrochloride) for children and young adults with Dravet syndrome.
On June 11, 2018, FDA Commissioner Scott Gottlieb released a complementary framework for gene therapies, noting that in the last 12 months the agency has approved three different gene therapy products. “This reflects the rapid advancements in this field,” Gottlieb stated.
AbbVie’s shares dropped about 2.2 percent in premarket trading this morning after releasing an update on its Phase III B-cell lymphoma trial.
Enzyvant Sciences, one of Vivek Ramaswamy’s numerous ‘Vant’ companies, filed a rolling submission of a Biologics License Application (BLA) for RVT-802 with the U.S. Food and Drug Administration for the treatment of DiGeorge Anomaly (cDGA), an immunodeficiency disease that impacts infants.
A report recently published by the National Academies of Sciences, Engineering, and Medicine concluded that institutions and researchers should regularly and carefully evaluate whether and how to provide study results to participants.
Otsuka Pharmaceutical, based in Tokyo, Japan, is acquiring Waltham, Massachusetts-based Visterra for $430 million in cash. The deal is expected to close in the third quarter of this year.
JOBS
IN THE PRESS